1. Field of the Invention
The present invention relates generally to medical methods and apparatus. More particularly, the present invention relates to the design and use of energy delivering probes for thermally coagulating and/or constricting hollow anatomical structures (HAS) including blood vessels such as the perforator veins which connect the superficial veins to the deep veins in the leg, truncal superficial veins of the leg (e.g., great saphenous vein, short saphenous vein, and the like), superficial tributary veins of the leg, internal spermatic veins (varicoceles), ovarian veins, gonadal veins, hemorrhoidal vessels, fallopian tubes, a-v malformations, a-v fistula side branches, esophageal varices, and the like. For purposes of illustration, apparatus and methods of the present invention for use in treating perforator veins will typically be described.
Perforator veins connect the deep venous system of a leg to the surface veins which lie closer to the skin. Normal or healthy perforator veins pass blood from the surface veins to the deep veins as part of the normal blood circulation. Incompetent perforator veins allow blood flow from the deep venous system to the surface veins, causing or contributing to problems, such as varicose veins, edema, skin and soft tissue changes, lipodermatosclerosis, chronic cellulites, venous ulcers, and the like.
Several procedures have been proposed for interruption of incompetent perforator veins. The “Linton” procedure requires a very long incision (knee to ankle) on the medial calf to expose the perforator veins. Individual veins may then be surgically dissected, ligated, and cut to prevent blood flow between the superficial and deep venous systems. A less invasive alternative has been developed by DePalma where individual incompetent perforator veins are identified along “Linton's Line” using ultrasound. Small incisions are then used to access the individual perforators for ligation and dissection. More recently, individual ligation and dissection of perforator veins has been performed using an endoscope inserted in the proximal calf.
Although generally effective, each of the above-described procedures requires surgical incisions followed by ligation and cutting of the veins. Thus, even at best, the procedures are traumatic to the patient and require significant surgical time. Moreover, the procedures are complex and often require a second surgeon to assist in the procedure.
For these reasons, it would be desirable to provide additional and improved techniques for disrupting incompetent perforator veins for the treatment of varicose veins, edema, skin and soft tissue changes, lipodermatosclerosis, chronic cellulites, venous ulcers, venous ulcers, and other conditions. Such procedures should preferably be minimally invasive, e.g., relying on an introducer sheath, cannula, catheter, trocar, or needle for gaining access to the perforator veins at the deep fascial plane. In particular, it would be desirable if the methods required few or no incisions, could be performed under a local anesthetic, would reduce post-operative healing time, as well as morbidity and complication rates, and would require only a single surgeon. In addition, it would be desirable to provide apparatus and methods which are useful for performing procedures on other tissues and hollow anatomical structures in addition to perforator veins. At least some of these objectives will be met by the inventions described herein below.
2. Description of the Background Art
The following U.S. patents and published applications describe radiofrequency (RF) probes having expandable electrode structures for treating incompetent venous valves and are commonly assigned with the present application: U.S. Pat. Nos. 6,401,719; 6,258,084; 6,237,606; 6,179,832; US2002/0148476; and US2001/0041888, the full disclosures of which are incorporated herein by reference. Probes as described in these patents have been used to treat refluxing veins, including perforating veins, as described in Whiteley et al. (2003) Venous Forum Abstracts, Phlebology 18:1. Other patents directed at treating veins with radiofrequency energy include U.S. Pat. Nos. 5,437,664 ; 3,301,258; and U.S. Pat. No. 3,733,99. The Cameron-Miller 80-8010 Coagulator intended for destroying tortuous tributaries and other varicosities is described in a brochure entitled An Exceptionally Successful Way to Treat Varicosities, published by Cameron-Miller, Inc., Chicago, Ill. (undated, but available prior to the invention herein). Radiofrequency probes with spaced-apart rings and other electrodes are described in U.S. Pat. Nos. 6,391,026; 6,332,880; 5,734,903; and 4,966,597. A radiofrequency probe with a ball electrode is described in U.S. Pat. No. 5,897,553. Other patents and published applications relating to radiofrequency probes and apparatus include: U.S. Pat. Nos. 6,669,672; 6,587,731; 6,539,265; 6,480,746; U.S. Pat. Nos. 6,346,102; 6,283,961; 6,267,758; 6,090,104; 6,077,261; 6,042,590; 6,041,679; 6,030,382; 5,976,131; 5,925,045; 5,893,849; 5,810,802; 5,766,167; 5,752,951; 5,709,224; 5,658,282; 5,643,257; 5,562,703; 5,556,396; 5,334,193; 5,281,216; 5,281,218; 5,122,137; 4,832,051; 4,765,331; 4,643,186; 4,548,207; 4,532,924; 4,481,953; 3,920,021; 3,230,957; 3,100,489; 2,022,065; 1,943,543; 8,337,59; US2002/0143325; and WO98/09575. Medical publications of interest include; O'Reilly, Kevin, Endovenous Diathermy Sclerosis as a Unit of The Armamentarium for the Attack on Varicose Veins; The Medical Journal of Australia, Jun. 1, 1974, p. 900; Watts, G. T., Endovenous Diathermy Destruction of Internal Saphenous; British Medical Journal, Oct. 7, 1972, p. 53; O'Reilly, Kevin, Endovenous Diathermy Sclerosis of Varicose Veins; The Australian, New Zealand Journal of Surgery, Vol. 47, No. 3, June 1977, pP. 339-395; O'Reilly, Kevin, A Technique of Diathermy Sclerosis of Varicose Veins; The Australian, New Zealand Journal of Surgery, Vol. 51, No. 4, August 1981, pP. 379-382; Cragg et al., Endovascular Diathermic Vessel Occlusion; Diagnostic Radiology, 144: 303-308, July 1982; Ogawa et al., Electrothrombosis as a Treatment of Cirsoid Angioma in the Face and Scalp and Varicosis of the Leg; Plastic and Reconstructive Surgery, Vol. 3, September 1982, pP. 310-311; Brunelle, et al., A Bipolar Electrode for Vascular Electrocoagulation with Alternating Current; Radiology, October 1980, Vol. 137, pP. 239-240; Aaron, Electrofulguration for Varicose Veins; The Medical Letter on Drugs and Therapeutics, Jul. 12, 1968, Vol. 10, No. 14, Issue 248, p. 54; and Corbett, Phlebology 17:36-40 (2002).
The following patents and pending applications are assigned to the Assignee of the present application and are generally related to the radiofrequency energy treatment of veins: U.S. Pat. Nos. 6,752,803; 6,689,126; 6,682,526; 6,638,273; 6,613,045; 6,322,559; 6,398,780; 6,263,248; 6,200,312; 6,165,172; 6,152,899; 6,139,527;6,135,997; 6,071,277; 6,036,687; 6,033,398; 6,014,589; 6,003,397; and U.S. Ser. Nos. 10/775,841; 10/738,488; 10/568,593; U.S. Pat. Nos. 7,041,098; 6,752,803; 6,769,433; 6,969,388; and 6,981,972. The full disclosures of each of thesepatents and pending application are incorporated herein by reference.